Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

Overview

Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 10, 2020

Arms, Groups and Cohorts

  • Pediatric patients
    • This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of comprehensive nutrition assessments in pediatric HCT patients
    • Time Frame: 1 year post-HCT
    • Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.

Secondary Measures

  • Dietary intake
    • Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
  • Determination of lean body mass measured using air displacement plethysmography (BOD POD)
    • Time Frame: baseline (pre-HCT); day 100 and 1 year post-HCT
  • Hand grip strength
    • Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
  • PedsQL Pediatric Quality of Life Inventory
    • Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
    • Participants 10 years or older
  • PedsQL Cognitive Functioning Scale
    • Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
    • Participants 10 years or older
  • Dietary Patient Self-Efficacy Survey
    • Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
    • Participants 10 years or older

Participating in This Clinical Trial

Inclusion Criteria

  • Pediatric hematopoietic cell transplant patients, aged 2-25 years. – Participants and/or at least one caregiver must speak, read and understand English. Exclusion Criteria:

  • Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan Rogel Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor

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